FDA warning

This drug has a black box
warning. This is the most serious warning from the Food and Drug Administration
(FDA). A black box warning indicates drug effects that may be dangerous.

Permanent vision problems warning. This drug may harm your peripheral vision, which is your
ability to see to the side while looking straight ahead. This may also cause
blurry vision. In severe cases, you may only be able to see what’s straight in
front of you. This effect is called tunnel vision. Vision loss from this drug
can be permanent. Because of this risk, this drug is only available to doctors
who are under a special program. This is called the Risk Evaluation and
Mitigation Strategy (REMS) program. Your doctor will test your vision often
during treatment with this drug and after you stop taking it. You have to agree
to be in the REMS program and have your vision tested regularly. Your doctor
will explain the REMS program to you.

Suicidal thoughts or actions

This drug may cause changes in your mood or behavior. It may raise your risk of suicidal thoughts or actions. If you have any thoughts of harming yourself, call your doctor right away.

Brain damage

This drug can harm your brain and cause other changes to your nervous system. Symptoms may include abnormal movements. This effect is more common in infants taking this drug. Your doctor will monitor you for brain damage during treatment. If you have brain damage or changes to your nervous system, your doctor will reduce your dosage or stop treatment.

Weight gain

Your doctor will monitor your weight while you take this drug. If you gain too much weight, your doctor may reduce your dosage or stop treatment.

What is vigabatrin?

This drug is a prescription drug. It’s available as an oral tablet. It’s also available as a powder that you mix into an oral solution.

Vigabatrin is only available as the brand-named drug Sabril. It’s not available as a generic drug.

Why it's used

This drug is used to treat complex partial seizures after other treatments haven’t worked. It’s also used to treat spasms in infants.

How it's used

How it's used

This drug belongs to a class of drugs called antiepileptics. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug works by increasing the amount of gamma-aminobutyric acid (GABA) in your nervous system. GABA is a substance that decreases the activity of your nervous system. This action reduces your risk of seizures.

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SECTION 2 of 4

vigabatrin Side Effects

Oral tablet

More common side effects

The side effects of vigabatrin are slightly different in children and adults.

Adults’ side effects can include:

vision problems, such as:

permanent vision loss

double vision

blurry vision

uncontrollable eye movement

fatigue

drowsiness

shaking

memory
problems

weight
gain

body
aches

walking
or coordination trouble

confusion

Children’s side effects can include the above, plus:

upper respiratory tract
infection, with symptoms such as:

nasal congestion

coughing

aggression

dizziness

headache

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

This drug may cause drowsiness. Don’t drive or do other activities that require alertness until you know you can function normally with this drug.

Disclaimer:
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

SECTION 3 of 4

vigabatrin May Interact with Other Medications

Oral tablet

Vigabatrin can interact with other medications, vitamins, or herbs you
may be taking. An interaction is when a substance changes the way a drug works.
This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your
medications carefully. Be sure to tell your doctor about all medications,
vitamins, or herbs you’re taking. To find out how this drug might interact with
something else you’re taking, talk to your doctor or pharmacist.

Medications that might interact with this drug

Interactions that increase the risk of side effects

Increased side
effects from other drugs: Taking vigabatrin with certain medications raises your
risk of side effects from those drugs. Examples of these drugs include:

Clonazepam

Side
effects can include drowsiness, dizziness, and decreased
control of your body movements.

Interactions that can make your drugs less effective

When other drugs are less effective: When
certain drugs are used with vigabatrin, they may not
work as well. This is because the amount of these drugs in your body may be
decreased. Examples of these drugs include:

Phenytoin

Disclaimer:
Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

Drug warnings

People with kidney problems

If you have kidney problems or a history of kidney disease, you may not be able to clear this drug from your body well. This may increase the levels of this drug in your body and cause more side effects.

People with vision problems

This drug may make your vision worse. These changes are permanent and can’t be reversed. Ask your doctor if this drug is safe for you.

People with depression or mood problems

This drug may make your depression or mood issues worse. This may lead to more suicidal thoughts or behaviors. Ask your doctor if this drug is safe for you.

Pregnant women

This drug is a category C pregnancy drug. That means two things:

Research in animals has shown adverse effects to the fetus when the mother takes the drug.

There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the pregnancy.

Women who are breast-feeding

This drug may pass into breast milk and cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

For children

It has not been confirmed that this drug is safe and effective for the treatment of complex partial seizures in people who are younger than 10 years.

This drug may be used to treat infantile spasms in children who are younger than 2 years.

When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

Allergies

This drug can cause a severe allergic reaction. Symptoms can include:

trouble breathing

swelling of your
throat or tongue

If you have an allergic reaction, call your doctor or local poison
control center right away. If your symptoms are severe, call 911 or go to the
nearest emergency room.

Don’t
take this drug again if you’ve ever had an allergic reaction to it.
Taking it again could be fatal (cause death).

SECTION 4 of 4

How to Take vigabatrin (Dosage)

Oral tablet

All possible dosages and drug forms may not be included
here. Your dosage, drug form, and how often you take the drug will depend on:

your
age

the
condition being treated

how
severe your condition is

other
medical conditions you have

how
you react to the first dose

The
dosage information below is for the conditions that this drug is most often
prescribed to treat. This list may not contain all conditions that your doctor
can prescribe this drug for. If you have questions about your prescription,
talk with your doctor.

What are you taking this medication for?

Complex partial seizures

Brand: Sabril

Form: Oral tablet

Strengths: 500mg

Form: Powder for oral solution

Strengths: 500mg

Adult dosage (ages 17 years and older)

Typical starting dosage: 500
mg twice per day for a total of 1,000 mg per day

Dosage increases:
Your doctor may increase your dosage each week by 500 mg per day until you
reach the recommended dosage of 3,000 mg per day (taken as two 1,500-mg doses).

Maximum dosage: 3,000
mg per day taken as two 1,500-mg doses

Child dosage (ages 10–16 years)

Children who weigh 60 kg (132 lbs.) or less:

Typical starting dosage:
500 mg per day in two 250-mg doses

Dosage increases:
Your doctor may increase your child’s dosage each week by 500 mg per day until they
reach the recommended dosage of 2,000 mg per day.

Maximum dosage: 2,000
mg per day in two 1,000-mg doses

Children who weigh
more than 60 kg (132 lbs.):

Typical starting dosage:
1,000 mg per day in two 500-mg doses

Dosage increases:
Your doctor may increase your child’s dosage each week by 500 mg per day until they
reach the recommended dosage of 3,000 mg per day.

Maximum dosage: 3,000
mg per day in two 1,500-mg doses

Child dosage (ages 0–9 years)

It has not been confirmed that this drug is safe and effective for use in children younger than 10 years.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dosage or a different schedule. This can help keep levels of this drug from building up too much in your body.

Special considerations

People with kidney
disease: Your
doctor may give you a lower dosage of this drug if you have kidney disease.

Mild
kidney problems: Your dosage may be decreased by 25%.

Moderate
kidney problems: Your dosage may be decreased by 50%.

Severe
kidney problems: Your dosage may be decreased by 75%.

Spasms in infants

Brand: Sabril

Form: Oral tablet

Strengths: 500mg

Form: Powder for oral solution

Strengths: 500mg

Adult dosage (ages 17 years and older)

This condition does not occur in this age group.

Child dosage (younger than 2 years)

Typical starting dosage: 50
mg/kg of body weight per day in two divided doses

Dosage increases: Your
doctor may increase your child’s dosage every three days by 25-50 mg/kg per day

Maximum dosage: 150
mg/kg per day

Child dosage (2 years of age and older)

This condition does not occur in this age group.

Special considerations

People with kidney
disease: Your
doctor may give you a lower dosage of this drug if you have kidney disease.

Mild
kidney problems: Your dosage may be decreased by 25%.

Moderate
kidney problems: Your dosage may be decreased by 50%.

Severe
kidney problems: Your dosage may be decreased by 75%.

Disclaimer:
Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.

This drug comes
with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all

If you don’t take
this drug at all, you’ll continue to have seizures. Stopping this drug suddenly
can cause seizures that won’t stop. Always talk to your doctor if you want to
stop taking your medication.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working
completely. For this drug to work well, a certain amount needs to be in your
body at all times.

If you take too much

You could have dangerous levels of the drug in your body.
Symptoms of an overdose of this drug can include:

loss of consciousness

drowsiness

dizziness

confusion

shortness of breath

low blood pressure (may make you
feel dizzy or lightheaded)

increase in seizures

If you think you’ve taken too much of this drug, call your
doctor or local poison control center. If your symptoms are severe, call 911 or
go to the nearest emergency room right away.

What to do if you miss a dose

Take your dose as soon as you
remember. If you remember just a few hours before your next scheduled dose,
take only one dose. Never try to catch up by taking two doses at once. This
could result in dangerous side effects.

You may need to show airport staff
the pharmacy label for your medication. Always carry the original
prescription-labeled box with you.

Don’t
put this medication in your car’s glove compartment or leave it in the car. Be
sure to avoid doing this when the weather is very hot or very cold.

Self-management

Watch for any changes in your
mood, behavior, and vision. Tell your doctor if you notice any changes.

If you’re taking
the powder for oral solution, you’ll receive packets containing 500 mg of the
drug. Ask your pharmacist how to prepare each dose. The number of packets you need
will depend on your dosage. To mix the solution:

Empty the correct number of packets
for your dose into a cup.

Add 10 mL of water for each packet.
For example, if you take 1500 mg, you will empty three packets into a cup and
add 30 mL of water.

Stir the solution until all of the
powder has dissolved.

Then
take the solution. You may need an oral syringe for child or infant dosing.
Your pharmacist may be able to give you one.

Clinical monitoring

You and your doctor should monitor certain health issues.
This can help make sure you stay safe while you take this drug. These issues
include:

Kidney function. Your doctor
may do blood tests to check how well your kidneys work. If your kidneys
aren’t working well, your doctor may lower your dosage of this drug.

Mental health and behavioral problems.
You and your doctor should watch for any unusual changes in your behavior
and mood. This drug can cause new mental health and behavior problems. It
can also make problems you already have worse. If you develop these
problems, your doctor may decrease your dosage or stop treatment.

Vision problems. You and your
doctor should watch for any symptoms of vision loss. If this drug affects
your vision, your doctor may lower your dosage or stop your treatment with
this drug.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

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Disclaimer:
Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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